UPPSALA, SwedenIn a new study, radical prostatectomy reduced deaths due
to prostate cancer but did not increase overall survival in men with newly
diagnosed, early-stage disease. The Scandinavian Prostatic Cancer Study Group
found that after a median 6.2 years of follow-up, there were no significant
differences in overall survival, but patients randomized to radical
prostatectomy were less likely to develop distant metastases than those
randomized to watchful waiting.
The survival and quality-of-life analyses were reported in the September
12 New England Journal of Medicine. Lead author on the survival analysis is
Lars Holmberg, MD, PhD. Lead author on the quality-of-life analysis is Gunnar
The study, which was initiated before the era of routine prostate-specific
antigen (PSA) testing, enrolled 695 men with clinical stage T1b, T1c, or T2
disease. Anna Bill-Axelson, MD, who is co-author on the Holmberg paper, told
ONI that the investigators were quite surprised to see a difference in
disease-specific mortality emerge so early in the study.
"The most important clinical implication of our study is that radical
prostatectomy reduces the risk of death from prostate cancer by 50%. The
study was designed to detect a much smaller difference, and we were surprised
that the difference was so prominent after such a short time," said Dr. Bill-Axelson,
who is in the Department of Urology, University Hospital, Uppsala, Sweden.
The difference in disease-specific mortality first became apparent after 5
years of follow-up (4.6% with watchful waiting vs 2.6% with radical
prostatectomy). At 8 years of follow-up, the prostate cancer death rate was
13.6% with watchful waiting and 7.1% with radical prostatectomy (relative
hazard 0.5, 95% CI 0.27 to 0.91, P = .02).
"The relative risk reduction was 50%, which translates into a small
absolute reduction, since the risk of death in both groups after this short
time is small. We think that only longer follow-up can determine if there
will be a benefit in overall survival. The difference at this time is too
small to be significant," Dr. Bill-Axelson said.
In an interview with ONI, Eric A. Klein, MD, Section Head for Urologic
Oncology, Cleveland Clinic Urological Institute, pointed out that 75% of
prostate cancer diagnoses in the United States are in men with nonpalpable
disease who have had biopsies because of elevated PSA levels, while only 10%
of the patients in the Swedish study were diagnosed at this early stage.